Clinical trials are designed to find specific answer to clinical question. Researchers need data to prove or disprove their theory. Hence, the quality of data comes into picture and becomes pivotal for success of whole clinical trial. For a Clinical Trial to be successful, it requires quality data to be collected. The quality of data is ensured by the Clinical Data Management department.
Clinical data management is defined as managing clinical data i.e., ensuring all clinical data are collected from various sources of clinical trials and ensure all data are accurate, timely, error-free, quality data for performing further analysis.
Clinical Data Manager (CDM) involves the collection of data (in proper format) and data cleaning (edit checks) for ensuring quality and managing data along with working of cross-functional teams. It is involved in processing clinical data through computer applications, web applications to support the removal, collection, and management of experimental data. It handles important information collected during medical research, also ensures high quality and integrity of data, and delivers results to a health science organization by creating accurate and valid data for the company.
The main objectives of the CDM are to collect high-quality data for analysis and further research and to ensure that the data provided to the company is of high quality and integrity for analysis by minimizing errors.
CDM works with many departments from the start of study to the finish. CDM being a lengthy process involving several different roles and responsibilities:
- Data Manager who supervises the team throughout the process. His/ her main duties are to:
- Coordinate data management activities
- Oversees the application of quality control producers
- Take responsibility for database locks
- Handles and verifies the data
- Manages data validation
- Create Data Management Plan (DMP), eCRF etc.
- Generate edits check in CDMS
- Work on Clinical Database Management Systems (CDMS) like RAVE, Inform, ORACLE CLINICAL, CLINTRIAL etc.
CDM works with many other departments and CDM’s responsibilities can overlap with other departments. CDM works with -
- CRF designer or Database Programmer who performs the CRF (Case Report Form) annotation. Their key responsibilities are to:
- Create study database
- Design data entry screens
- Validates the edit checks with a dummy dataset
- Clinical Data Coordinator who designs the Case Report Form. They must create:
- CRF Instructions
- Discrepancy protocols
- Medical Coder who codes variations, such as adverse events and medical histories.
- Quality control associate who checks the accuracy of data entry and performs data audits.
- Data entry associate who tracks receipt of the CRF pages and enters the data into the database.
- Investigators and clinicians who collects the data during the study using CRFs.
- Site and data personnel enters the data into the database following receipt of the CRF pages.
- Biostatisticians conduct statistical analysis of the study data.
- Medical writers prepare the study reports.
Why CDM is important?
Clinical Research is very sensitive and crucial, as the result should demonstrate that the product is safe and meets the requirements. CDM provides:
- Assurance to data quality
- Protection from data loss
- True representation of trial in study database
- Formatted dataset for optimal and timely usability and many more.
Managing Clinical Data while securing is a bit challenging, hence there are tools made for CDM to make it function easier and more accessible to people. DMP contain all the work that is needed for a clinical research study. (Data Management Plans) & DMS (Data Management System) are designed to help clinical research studies meet CDM requirements.
To get the clinical research accurate, integrate and of high-quality Clinical Data Management can be the best choice for any life science organization.
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